Global News

PPD appoints Jon Denissen VP GMP laboratory services

Friday, April 3, 2015 10:18 AM

Pharmaceutical Product Development (PPD) has appointed Jon Denissen, Ph.D., as vice president of good manufacturing practices (GMP) laboratories. Denissen brings over 25 years of experience in the pharmaceutical and CRO industries. He is based in PPD’s GMP lab facility in Middleton, Wis.

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Quest Diagnostics

Clinical trials prove Canada's VSV-EBOV Ebola vaccine safe and effective

Thursday, April 2, 2015 02:46 PM

Canada's VSV-EBOV Ebola vaccine proved to be safe and effective in a phase I clinical trial, according to findings published in the New England Journal of Medicine. These studies were performed at the Walter Reed Army Institute of Research and the National Institute of Allergy and Infectious Diseases to explore the experimental vaccine's safety and what immune response it evokes when administered at different dosages.

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Enzalutamide, bicalutamide demonstrate positive results in Strive trial

Thursday, April 2, 2015 01:38 PM

Astellas Pharma and Medivation has announced topline results from the phase II STRIVE trial comparing enzalutamide with bicalutamide in a study population of men with non-metastatic or metastatic castration-resistant prostate cancer. The study achieved its primary endpoint demonstrating a statistically significant increase in progression-free survival (PFS) for enzalutamide compared with bicalutamide (Hazard Ratio = 0.24; 95% Confidence Interval, 0.18-0.32; p<0.0001). Median PFS was 19.4 months in the enzalutamide group compared with 5.7 months in the bicalutamide group.

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TPG completes acquisition of Aptalis, renames company Adare Pharmaceuticals

Thursday, April 2, 2015 01:08 PM

Aptalis Pharmaceutical Technologies has announced that its divestiture from Actavis to TPG, a Texas-based global private investment firm, has been completed. The company also announced its new name is Adare Pharmaceuticals, and John Fraher, who was president of Aptalis Pharmaceutical Technologies, has been named CEO. He is joined by key executives from his current management team.

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Certara launches Cardiac Safety Simulator V2.0

Thursday, April 2, 2015 01:07 PM

Certara, a Princeton, N.J.-based global biosimulation technology-enabled consultancy, has launched version 2.0 of its Cardiac Safety Simulator (CSS), which has become a standalone product for the first time.

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Ipsen opens new Massachusetts R&D center

Thursday, April 2, 2015 01:06 PM

Ipsen, a global specialty-driven biotechnological group based in France, has announced the opening of its new R&D center, Ipsen Bioscience, in Cambridge Mass., a U.S. hub for biomedical research and innovation. Ipsen’s strategic decision to invest in the Ipsen Bioscience facility in Cambridge is an important element of the company’s open innovation strategy and its goal of broadening its partnerships with the American biotech, medical and scientific communities.

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Obama administration releases National Action Plan to combat antibiotic-resistant bacteria

Thursday, April 2, 2015 12:59 PM

The White House has released a comprehensive plan that identifies critical actions to be taken by key Federal departments and agencies to combat the rise of antibiotic-resistant bacteria. The National Action Plan for Combating Antibiotic-Resistant Bacteria, which was developed by the interagency Task Force for Combating Antibiotic-Resistant Bacteria in response to Executive Order 13676: Combating Antibiotic-Resistant Bacteria, outlines steps for implementing the plan.

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Covance, Sihuan partner in preclinical and clinical portfolio development

Thursday, April 2, 2015 12:56 PM

LabCorp, a North Carolina-based healthcare diagnostics company, and Shandong XuanZhu Pharma, the wholly-owned subsidiary for innovative drug R&D of Sihuan Pharmaceutical, have inked a long-term partnership with Covance Drug Development (part of LabCorp) to support the global development of Sihuan’s drug candidate pipeline.

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Horizon Pharma to acquire Hyperion Therapeutics for $1.1B in cash

Wednesday, April 1, 2015 01:59 PM

Horizon Pharma, based in Ireland, will acquire all of the issued and outstanding shares of California-based Hyperion Therapeutics’ common stock for $46 per share in cash, or approximately $1.1 billion on a fully diluted basis.

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Teva to acquire Auspex for $3.5 billion

Wednesday, April 1, 2015 01:04 PM

Teva Pharmaceutical Industries, headquartered in Israel, and Auspex Pharmaceuticals, based in California, have agreed to merge. Teva will commence a tender offer for all of the outstanding shares of Auspex at $101 per share in cash, for a total of approximately $3.2 billion in enterprise value and approximately $3.5 billion in equity value.

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April 27

Doctors, patients in the U.S. and U.K. agree: Mobile health apps are good for our health

AARP teams with Georgia Tech's HomeLab, Pfizer and UnitedHealthcare to test wearables with consumers 50+

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PSI, INC Research, Chiltern best with sites
Strategic outsourcing prioritizing, improving site relationships

Regulatory compliance an increasing burden on sites
Increased staff time, materials, storage eroding site operating profit

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Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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